MAUDE Adverse Event Report: STRYKER SPINE-US 5.5X45 POLYAXIAL SCREW; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Model Number	482615545
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Paralysis (1997)
Date of Event	11/29/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device has been explanted and discarded.
Event or Problem Description
Physician reported that after intervertebral posterior lumbar interbody fusion (plif) of l4-l5/s a patient became paralyzed and the l5 xia serrato 5.5x45 polyaxial screw looked as if it had come out of the pedicle in a post-operative x-ray.Upon revision surgery, it was observed that the nerve root had been damaged.The screw was removed and replaced with a different-sized screw at a different insertion angle.Paralysis resolved upon removal of screw.
Additional Manufacturer Narrative
Corrected data g.4.: additional information received clarified that a stryker representative was not made aware of the event until 8/jan/2020.Corrected from (b)(6) 2019 to (b)(6) 2020.
Event or Problem Description
Physician reported that after intervertebral posterior lumbar interbody fusion (plif) of l4-l5/s a patient became paralyzed and the l5 xia serrato 5.5x45 polyaxial screw looked as if it had come out of the pedicle in a post-operative x-ray.Upon revision surgery, it was observed that the nerve root had been damaged.The screw was removed and replaced with a different-sized screw at a different insertion angle.Paralysis resolved upon removal of screw.
Additional Manufacturer Narrative
Visual, dimensional, material and functional analysis could not be performed as the device was not returned.Device and complaint history records review could not be performed as a valid lot code was not provided and could not be obtained.Per instructions for use: peripheral neuropathies, nerve damage, heterotopic bone formation and neurovascular compromise, including paralysis, loss of bowel or bladder function, or foot-drop may occur.Serious complications may be associated with any spinal surgery.These complications include, but are not limited to: genitourinary disorders; gastrointestinal disorders; vascular disorders, including thrombus; bronchopulmonary disorders, including emboli; bursitis, hemorrhage, myocardial infarction, infection, paralysis or death.Without x rays or the product, a definite root cause cannot be determined.Based on the information provided, the screw contact the nerve root and function was restored after removing the screw and using a different trajectory angle.Based on this information, it is probable that with the initial trajectory chosen, the screw contacted the nerve causing the adverse effects.Changing of the trajectory was able to alleviate the patient's symptoms.
Event or Problem Description
Physician reported that after intervertebral posterior lumbar interbody fusion (plif) of l4-l5/s a patient became paralyzed and the l5 xia serrato 5.5x45 polyaxial screw looked as if it had come out of the pedicle in a post-operative x-ray.Upon revision surgery, it was observed that the nerve root had been damaged.The screw was removed and replaced with a different-sized screw at a different insertion angle.Paralysis resolved upon removal of screw.

• Brand Name: 5.5X45 POLYAXIAL SCREW
• Common Device Name: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• MDR Report Key: 9638653
• Report Number: 3005525032-2020-00016
• Device Sequence Number: 418521
• Product Code: NKB
• UDI-Device Identifier: 07613327352054
• UDI-Public: 07613327352054
• Combination Product (Y/N): N
• PMA/510(K) Number: K170496
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 482615545
• Device Catalogue Number: 482615545
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/29/2019
• Supplement Date Received by Manufacturer: 01/08/2020; 03/30/2020
• Initial Report FDA Received Date: 01/28/2020
• Supplement Report FDA Received Date: 02/04/2020; 04/28/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention